Injection device having a dosing element and a preloaded discharge spring

ABSTRACT

A driving and dosing device for an injection device includes: a housing, a dosing element gripped by a user, an actuating element actuable by the user to discharge the set dose, a propulsion element for acting on a piston to discharge the set dose, a spring configured to act between the propulsion element and an abutment, which is preloaded so as to discharge a maximum dischargeable product quantity in a plurality of individual discharges, a rotation element configured to rotate relative to the housing and a clutch configured for releasably engaging the rotation element. Releasing the clutch permits the rotation element to rotate relative to the housing when the actuating element is actuated, blocks the rotation of the rotation element relative to the housing when the actuating element is released, and by rotation of the rotation element, the spring is permitted to move the propulsion element in the discharge direction.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of International Patent ApplicationNo. PCT/EP2013/056095 filed Mar. 22, 2013, which claims priority toEuropean Patent Application No. EP 12 162 777.2 filed Mar. 30, 2012, theentire contents of each are incorporated herein by reference.

BACKGROUND

The invention relates to an injection device for administering a liquidproduct, particularly a medicine, such as insulin for diabetes therapy.In particular, the invention relates to a driving and dosing device forsuch an injection device.

An injection device having a dose indicating drum and a drive spring isknown from the prior art, namely WO 2008/031237 A1. The drive spring isa coiled spring, which is wound in a spiral shape from a strip-shapedmaterial. When the product dose is being set, the spring is tensionedwith a rotational movement. In order to inject a dose, a piston rod iscoupled to the spring by means of an actuating button at the proximalend of the device, whereby the spring can output the energy storedtherein to the piston rod, whereby the piston rod is moved in thedischarge direction. To set a new dose, the spring is again cocked byrotating the dosing knob, and so on. This is repeated until the productcontainer has been emptied.

An injection device with a helical spring is also known from U.S. Pat.No. 5,104,380, the spring being likewise cocked rotationally duringdosing, so that the helical spring can also be referred to as a torsionspring. The spring, cocked by rotation before each product discharge,transfers its energy to the piston rod in order to propel the pistonrod.

WO 2006/77466 A2 discloses an injection device that has a directmechanical drive between the person applying the injection force and thepiston rod, which is displaced in the distal direction for the injectionof the medicine.

SUMMARY

One problem addressed is that of specifying a driving and dosing devicefor an injection device used to administer a liquid product, whichenables easier usage of the device for the user, in particular a simplersetting of the dose.

This problem is solved by the features and refinements of the claims,the description and the figures.

Advantageous refinements involve providing a driving and dosing devicefor an injection device with an improved dose indication that gives theuser of the device better information about the operating condition ofthe device and may involve providing a dose indicating element with adosage scale, a pointing device and optionally a bearing element asdescribed herein.

The drive mechanism of the present disclosure includes a housing. Thehousing is preferably sleeve-shaped and/or elongated in shape. Thehousing can extend along a longitudinal axis, for example.

The housing can optionally accommodate a product container or can itselfconstitute the product container. The housing can be in one or moreparts. For example, the housing can form a proximal housing part thatcomprises or has the driving and dosage device. The housing canadditionally have a product container holder, which receives the productcontainer such as a carpule and is connected to the housing or theproximal housing part. This connection can be such that the productcontainer holder and the housing or the proximal housing part isnon-detachable after connection, i.e. only detachable by destroyingconnecting elements. Such a solution is particularly advantageous forsingle-use injection devices, which can be disposed of as a whole afterthe product contained in the product container has been completelydischarged.

Alternatively, the product container holder can also be detachablyconnected to the housing, whereby it is possible, although also lesspreferred, to use the driving and dosing device several times ifnecessary, i.e. to replace an empty product container with a filledproduct container.

The housing is principally used in order to be gripped by the user ofthe device. In particular, the housing can have a substantiallycylindrical shape. The housing can have a pointing device, particularlya window, by means of which or through which the currently set dosagecan be read out, preferably from a scale of the dose setting element.

In a first advantageous aspect, the driving and dosing device, which inparticular forms an injection device together with the container,comprises a dose indicating element, across the periphery of which adose scale is arranged, in addition to the housing. The dose indicatingelement can be annular in cross section, for example. The doseindicating element can be a dose indicating drum or a dose indicatingring, for example. The dose scale can extend over the periphery of thedose indicating element, preferably in a helical shape. The dose scalepreferably comprises a plurality of values, which are arranged one afteranother and produce the dose scale. These are preferably numericalvalues that indicate the desired product dose in international units(IU).

Alternatively, the dose scale can be arranged without a pitch over theperiphery of the dose indicating element, such as the dose indicatingring, in which case the scale values then repeat after a revolution ofthe dose indicating element. In a dose scale with a pitch, i.e. ahelical dose scale, the dose indicating element, particularly the doseindicating drum, can be rotated more than one revolution without thescale values repeating, whereby higher or more scale values canadvantageously be represented.

The driving and dosing device further comprises a pointing device,wherein the dose indicating element, in order to set the dose, can berotated relative to the pointing device and particularly about arotational axis that preferably corresponds to the longitudinal axis ofthe driving and dosing device and/or the dose indicating element. Thismovement can be a purely rotational movement, i.e. a rotational movementwithout superimposed axial movement. Preferably an axial movement issuperimposed on the rotational movement, whereby the dose indicatingelement is screwable relative to the pointing device in order to set thedose to be administered. A screwable dose indicating element can beadvantageously combined with a helical dose scale, the screwing movementand the dose scale preferably having the same pitch. A dose indicatingelement without axial movement can be advantageously combined with apitch-free dose scale.

A value of the dose scale that corresponds to the set dose can be readout by means of the pointing device, which is preferably formed on thehousing. The pointing device can be a window, for example, which can beformed by an opening in the housing or by a transparent insert.Alternatively or optionally, the pointing device can be an arrow or havean arrow, which marks the value of the dose scale corresponding to theset dose in addition to the window. This is advantageous if a secondvalue appears in the window, at least partially, in order to ensure anunambiguous choice of dose, for example. The pointer can be a protrusionor an imprint or a notch or the like.

The driving and dosing device comprises a dosing element, which can beformed as a dosing knob for example, and can optionally be referred toas a setting element. The dosing element can preferably be gripped bythe user (patient, physician, medical assistance personnel) of thedriving and dosing device and preferably constitutes an external, moreparticularly externally accessible, surface of the driving and dosingdevice.

To adjust the dose to be discharged or administered, the dosing elementis preferably gripped by the user and rotated relative to the housing,and in particular to the pointing device, about an axis of rotation,which preferably corresponds to the longitudinal axis of the driving anddosing device, which is designed in an elongated shape for example. Thedosing element is preferably connected axially fixedly to the housing,more particularly secured against displacement along a longitudinal axisof the housing, whereby the intuitive handling of the device by the useris advantageously facilitated, because the user needs only to carry outa rotational movement of the dosing element to adjust the dose.

In particular, the dose indicating element can be secured againstrotation relative to the dosing element at least during thedose-setting, but connected or coupled to the dosing element so as to beaxially displaceable. For intuitive operation, it is advantageous if,when the dosing element is rotated by a given angle of rotation, thedose indicating element is rotated by the same angle of rotation and thetwo may be slaved in rotation.

The driving and dosing device can have an actuating element, e.g. in theform of an actuating button. The actuating element can form an outersurface of the driving and dosing device and/or can be accessible fromthe outside. The actuating element can be formed on the proximal end, inparticular the rear end, of the driving and dosing device or canconstitute this end. In this manner, the actuating element canadvantageously be actuated, particularly pressed, with the thumb of thehand that is gripping the housing. The actuation can be ended byreleasing the actuating element. “Actuating” is understood to mean thedisplacement of the actuating element into the driving and dosingdevice, more particularly in the distal direction, which can affect thedischarging of a product. The actuating element is advantageouslydisplaceable relative to the dosing element and in particular can bereceived by the dosing element so as to be displaceable axially.

The actuating element can advantageously be displaceable, moreparticularly actuatable, against the force of a spring, particularly areturn or coupling spring, whereby this spring is cocked. By beingreleased, this spring can reset the actuating element, more particularlydisplace it relative to the dosing element, specifically in the proximaldirection or out of the driving and dosing device.

The driving and dosing device further comprises a bearing element, withwhich the dose indicating element is engaged. This engagementadvantageously effects the rotational or screwing movement of the doseindicating element relative to the pointing device. For example, theengagement between the dose indicating element and the bearing elementcan be a threaded engagement. In particular, the bearing element canhave an external thread and the dose indicating element an internalthread, these threads engaging with one another and thereby causing thedose indicating element to be screwable relative to the bearing element.

The dose indicating element can be rotated or screwed between a maximumdose position and a zero dose position. In the zero dose position, thedose or the digit “0” can advantageously be readable in the pointingdevice. In the maximum dose position, the maximum product dose that canbe discharged with the driving and dosing device can advantageously bereadable.

The dose indicating element can be blocked in the zero dose positionagainst rotation in one rotational direction, namely the rotationaldirection that would cause a dose of less than zero to be set. In thezero position, the display element can preferably only be rotated in adirection of rotation that causes an increase of the dose. In themaximum dose position, the dose indicating element is preferably blockedagainst rotation in one rotational direction, namely the rotationaldirection that would cause the setting of a dose greater than themaximum settable dose. Preferably, the dose indicating element in themaximum dose position can only be rotated in the direction that causes areduction of the product dose.

For example the dose indicating element can have a stop that strikesagainst a mating stop in the zero dose position and thus preventsrotation in one rotational direction. The same or an additional stop onthe dose indicating element can prevent rotation of the dose indicatingelement past the maximum dose. In particular, an additional mating stop,namely a maximum dose mating stop, can be provided for this purpose. Theother mating stop can accordingly be referred to as the zero dose matingstop. Thus the dose indicating element can have a zero dose stop for thezero dose mating stop and a maximum dose stop for the maximum dosemating stop. The stop or the stops are preferably active in thecircumferential direction and/or in the axial direction.

The driving and dosing device is characterized in a first aspect in thatthe bearing element, together with the dose indicating element, isdisplaceable relative to the housing and along the axis of rotation,particularly in the distal direction. This aspect can advantageouslyimprove the driving and dosing device according to a second aspectdescribed herein. Alternatively, the dose indicating element can have athread that is engaged with the housing. Thereby the dose indicatingelement can be displaced back and forth relative to the housing but notindependently of the screwing movement, particularly not with a purelyaxial movement.

The actuating element is preferably coupled to the bearing element insuch a manner that a displacement of the actuating element relative tothe housing and/or the dosing element causes a displacement of thebearing element relative to the housing and/or the dosing element,particularly along the longitudinal axis of the driving and dosingdevice.

Because the dose indicating element is engaged with the bearing elementand the bearing element can be displaced relative to the housing andalong the axis of rotation, the dose indicating element can also bedisplaced relative to the housing and along the axis of rotationindependently of the rotating or screwing movement that the doseindicating element undergoes during setting of the dose. The driving anddosing device according to the second aspect can basically also becombined advantageously with the alternative dose indicating element,which is in threaded engagement with the housing or an element fixedrelative to the housing. In this alternative, the bearing element can beformed by the housing or be a part of the housing, wherein the bearingelement can then be secured rotationally and axially in relation to theremainder of the housing.

The fact that the bearing element has been displaced together with thedose indicating element can advantageously be read out on the pointingdevice or the dose indicating element. In this way, the user can monitorthe operating status of the driving and display device, i.e. whether thedriving and display device, and in particular the actuating element, isor is not actuated for a discharge.

In a preferred variant, the actuating element and/or the bearing elementcan be displaceable together with the dose indicating element relativeto the pointing device, the housing and along the axis of rotation. Inthe area of the pointing device, particularly in the window of thepointing device, a marking different from the dose scale can appear whenthe bearing element has been displaced. The marking is preferablyarranged on the dose indicating element. If the bearing element has notbeen displaced, more particularly the driving and dosing device has notbeen actuated for discharging the product, the marking can be arrangedoutside the pointing device, for example concealed by the housing orsome other element. If the bearing element has been displaced, inparticular if the driving and dosing device has been actuated fordischarging the product, the marking can emerge from the covered area,so that it appears or is readable on or in the pointing device. If theactuation of the driving and dosing device has been interrupted orterminated, the bearing element can return to the original position,whereby the marking preferably is removed from the area of the pointingdevice and in particular is concealed.

In an alternative variant, the actuating element and/or the bearingelement can be displaceable together with the dose indicating elementand the pointing device relative to the housing and along the axis ofrotation. The pointing device can be a screen, for example, or at leastperform the function of a screen. For example, the pointing device canbe connected to the bearing element at least axially fixedly, preferablyalso rotationally fixedly. The bearing element can basically form thepointing device. It is of course also possible for the pointing deviceto be a part separate from the bearing element. The pointing device canbe sleeve-shaped, for example

In this variant, the displacement of the bearing element can cause amarking, which is arranged or formed alongside or on top of the pointingdevice and differs from the dose scale, to appear in the area of thepointing device. For example, the pointing device can be arranged insidethe housing. The marking of the pointing device can be concealed by thehousing or another element in the non-actuated state of the driving anddosing device. If the driving and dosing device, more particularly theactuating element, is actuated and thus the dose indicating element isdisplaced together with the pointing device, the marking can emerge fromits covering, so that the marking is visible or readable. If theactuation is interrupted or terminated, the dose indicating element,together with the pointing device and the bearing element, can bedisplaced back into its initial position and therefore the marking isagain arranged under the cover.

It is generally preferred that a spring, particularly a coupling orreturn spring, is cocked for actuating the driving and dosing device inorder to discharge a product. In other words, the bearing element can bedisplaced during actuation against the force of the spring, particularlya spring of this type, from a non-actuated position into an actuatedposition. The spring can be a helical spring or a coil spring, forexample, acting as a compression spring. This spring has the furthereffect of resetting the bearing element to the starting position ornon-actuated position if the actuation is interrupted or ended. Inparticular, the bearing element is displaced in the distal directionduring actuation. The bearing element is pushed back into its originalposition by means of the spring if the actuation is interrupted orended.

Actuating the actuating element has the effect in particular ofdisplacing the bearing element together with the dose indicating elementrelative to the housing and along the axis of rotation. In the broadersense, the actuation of the actuating element can displace a propulsionelement, the distal end of which is provided to act in the distaldirection, more particularly the discharging direction, on a piston ofthe product container mounted or mountable on the driving and dosingdevice. The actuating element can be arranged at the proximal end, i.e.rear end, of the driving and dosing device or can form the proximal endof the driving and dosing device. Alternatively, the actuating elementcan be arranged laterally on the housing and/or between the distal endand the proximal end of the driving and dosing device. In general, theactuating element can be formed in the manner of an actuating button.During actuation, the actuating element is preferably displaced relativeto the housing or the dosing element. In particular, the user of thedevice can advantageously actuate the actuating element with the thumbof the hand that is gripping the housing of the driving and dosingdevice, for example.

The actuating element is preferably connected to the bearing element insuch a manner that it displaces the bearing element during actuation,more particularly via a clutch element which can be connected axiallyfixedly and rotatably to the bearing element for example.

In generally preferred embodiments, the actuation of the actuatingelement can cause the dose indicating element to be rotated,particularly screwed, relative to or on the bearing element or thehousing, more particularly in a direction such that the values movingpast the pointing device during the rotational movement count down onthe dose scale. The angle of rotation of the dose indicating element andthe discharge stroke of the propulsion element preferably have aproportional relationship, more particularly at every point during thedose discharging. This makes it possible to implement a real-timedisplay, which counts down during dose discharging until it finallyreaches the value 0, at which point the discharging of the dose inquestion is complete. If the actuation for discharging is interruptedduring the back-rotation of the dose indicating element, the doseindicating element indicates the remaining amount necessary for thedischarging of this dose.

In one variant, the drive and dosing device can be designed such thatthe energy required for the back-rotation of the dose indicating elementand/or the displacement of the propulsion element in the distaldirection must be applied manually, more particularly by a force exertedon the actuating element by the user. For example, the dose-settingelement, more particularly the dosing knob, can be screwed out of thehousing for setting the dose, being screwed back into the housing fordose discharging by actuation of the actuating element.

In a preferred alternative variant, the drive and dosing device can bedesigned such that the energy required for the back-rotation of the doseindicating element and/or the displacement of the propulsion element inthe distal direction is exerted automatically, more particularly bymeans of a spring contained in the driving and dosing device, inparticular a discharge spring, in which the required energy is or can bestored. For example, the spring energy stored in the discharge springcan be output upon actuation of the actuating element to the doseindicating element and/or the propulsion element, so that the doseindicating element is rotated back and the propulsion element isdisplaced in the distal direction. The discharge spring can be coupledto the dosing element for example in such a manner that a rotation ofthe dosing element cocks the discharge spring during the dose-setting.The spring can then store the energy required for the set dosage.

In a preferred alternative, the spring can already be cocked withsufficient energy upon delivery of the driving and dosing device thatthe energy suffices for several discharges of the product dose, inparticular for discharging the entire product that can be dischargedfrom the product container. In this alternative, the dosing element canbe decoupled from the spring during dose-setting, i.e. not coupled tothe discharge spring in such a manner that a rotation of the dosingelement cocks the spring. In this manner the dosing element can berotated by the user to set the dose with considerably less forceexertion.

The dosing element, more particularly the dosing knob, can surround orreceive the actuating element, specifically the actuating button. Thusthe dosing element and the actuating element can form the proximal endof the driving and dosing device. The actuating element is preferablydisplaceable relative to the dosing element for actuation.

In embodiments in which the energy required for the discharging isautomatically provided, the dosing element can preferably be arrangedaxially fixedly or rotatably relative to, and in particular on, thehousing.

In a second aspect, from which, in particular, the present inventionproceeds and which can be combined with features of the first aspect,particularly with or without the feature that the bearing element isdisplaceable together with the dose indicating element relative to thehousing and along the rotational axis, the driving and dosing device canhave a propulsion element, the distal end of which acts on a piston,more particularly indirectly or preferably directly. The piston can bepart of a product container such as a carpule mounted or mountable onthe driving and dosing device. In a broader sense, the propulsionelement can be considered a piston rod, wherein the propulsion elementneed not necessarily be solid, but can also be hollow, e.g.sleeve-shaped. A flange, rotatable for example, that presses against thepiston, can optionally be arranged at the distal end of the propulsionelement. It is generally preferred that the distal end of the propulsionelement presses against the piston. The propulsion element is preferablydisplaceable relative to the housing along the longitudinal axis of thedriving and dosing device.

The driving and dosing device can have an abutment and preferably aguide, wherein the propulsion element is displaceable relative to theabutment and preferably also relative to the guide in a direction, moreparticularly the distal direction or the discharging direction, in orderto bring about the discharging of the set product dose. The propulsionelement can preferably be moved by means of or on the guide along thelongitudinal direction of the driving and dosing device in a straightline or axially. In particular, the propulsion element can berotationally fixed relative to the abutment and/or the guide and/or thehousing. In an alternative embodiment, the propulsion element can berotatable relative to the abutment for the housing combined with alongitudinal movement, i.e. screwable relative to the abutment, althoughthis is less preferred. In general, the guide and/or the abutment can beformed from the housing, particularly a sleeve-shaped housing part or asleeve-shaped element fixed to the housing, for example.

The propulsion element and the guide, formed in particular by thehousing, can be in an engagement that prevents a rotation of thepropulsion element relative to the abutment or the housing, but allowsan axial movement or a screwing movement of the propulsion elementrelative to the abutment of the housing. The guide can be an axial guideor a thread with a non-self locking thread pitch.

The guide or the housing section, more particularly an inner sleeve theforms the abutment and/or the guide, can preferably surround thepropulsion element, in a sleeve-like manner, and/or can be fixedrelative to the housing or formed by the housing. An annular gap can beformed between this sleeve-shaped housing part and the external,preferably also sleeve-shaped, housing part, which brings the advantagethat an optionally present dose indicating element, particularly anindicating drum, can be received therein. This results in that thelength of the driving and dosing device can be kept small.

According to the second aspect, the driving and dosing device can haveat least one, e.g. exactly one, two or three, discharge springs actingbetween the propulsion element or a rotation element and the abutmentand in particular arranged between them. The at least one spring can besupported on the propulsion element and/or the abutment, for example.The single discharge spring, for example, can be supported at its distalend on the propulsion element, and at its proximal end, on the abutment.In particular, the at least one discharge spring can be arranged insidethe guide or the sleeve-shaped housing part forming the guide. If thepropulsion element is sleeve-shaped, the at least one discharge springcan be arranged inside the propulsion element. Alternatively, a firstdischarge spring and a second discharge spring can be arrangedkinematically between the propulsion element and the guide or thesleeve-shaped housing part forming the guide. The first discharge springcan surround the second discharge spring, for example, or vice versa. Inparticular, the second discharge spring can be arranged concentricallywith the first discharge spring. The first discharge spring and thesecond discharge spring can be connected in parallel or in series forexample. Springs connected in parallel means in particular that thefirst and the second discharge springs are each supported at theirdistal end on the propulsion element and on the abutment at theirproximal end. Thereby the spring constants of the first and seconddischarge springs can be added up to a total spring constant. Springsconnected in series means in particular that the distal end of eitherthe first or the second discharge spring is braced against the proximalend of the other of the first and second discharge springs, particularlydirectly or preferably indirectly, such as via an intermediate element.For example, the first discharge spring can be supported on the abutmentand the intermediate element, and the second discharge spring can besupported on the intermediate element and the propulsion element. Thedistal end of the first discharge spring can be arranged distally fromthe proximal end of the second discharge spring, for instance. Due tothe intermediate element, the spring force of the first spring can betransmitted from its distal end onto the proximal end of the seconddischarge spring. In particular, the intermediate element can besleeve-shaped and arranged in an annular gap between the first andsecond discharge springs. Springs connected in series make it possibleto have a spring force that remains equal over a relatively long springtravel.

For example, the at least one discharge spring, more particularly thefirst and second discharge springs, can be a coil or helical spring thatacts as a compression spring or torsion spring. The at least onedischarge spring is cocked and acts on the propulsion element in such amanner that it attempts to displace the propulsion element in the distaldirection, i.e. discharge direction, relative to the abutment. The atleast one discharge spring is cocked with sufficient energy in thedelivery state of the driving and dosing device that it can dischargethe maximum or total quantity of injectable product in the productcontainer in multiple individual discharges, i.e. in multiple dischargesof individual product doses. The driving and dosing device is designedsuch that the next dose to be discharged is reset after each individualdischarge or product dose discharge. In contrast to embodiments in whicha discharge spring must be recocked for every dose adjustment, easierdose adjustment can be achieved with the spring cocked to the energyrequired for discharging the maximum product quantity injectable fromthe product container, since the dosing element, which is rotatablerelative to the housing for setting the dose, is then easier to rotatebecause the spring does not need to be cocked while adjusting the dose.This increases the convenience of using the device.

The driving and dosing device can additionally comprise a rotationelement, the location of which has the effect that the spring outputsenergy to the propulsion element, whereby the propulsion element ismoved in the distal direction. The rotation element preferably takes onthe function of a control element, wherein the rotation of the rotationelement by a defined angle of rotation causes the advancement of thepropulsion element by a defined discharge stroke. By selectivelyreleasing or blocking rotation of the rotation element relative to thehousing, the spring can be allowed to move the propulsion element in thedistal direction relative to the abutment, or not to move it. Inparticular, the rotation element can be coupled to the actuating elementsuch that, upon actuation of the actuating element for a productdischarge, the rotation element is released for a rotation relative tothe housing in order to discharge the product, and it is blocked fromrotation relative to the housing if the actuating element is notactuated. In particular, a clutch that effects the release and lockingof rotation of the rotation element relative to the housing can bearranged between the actuating element and the rotation element.

The clutch can advantageously release the rotation of the rotationelement relative to the housing if the actuating element is actuated,and can block the rotation of the rotation element relative to thehousing when the actuating element is released.

The discharge spring is preferably arranged kinematically between thepiston of the product container and the rotation element. In this way,it is possible to prevent the discharging energy provided by thedischarge spring from having to run largely via the rotation element aswould be the case if the rotation element were arranged kinematicallybetween the discharge spring and the piston. Thereby the rotationelement can be designed more simply. In particular this can cause the atleast one discharge spring to drive the propulsion element and thepropulsion element to drive the rotation element.

In particular, the propulsion element can be arranged kinematicallybetween the discharge spring and the rotation element.

In particular, the angle of rotation of the rotation element can beproportional to the discharge stroke of the piston or the propulsionelement. This can be achieved by selectively blocking or releasing therotation element.

The rotation element can advantageously be in an engagement,particularly a threaded engagement, with the propulsion element. Thethread pitch of this threaded engagement has the effect that in case ofa complete revolution of the rotation element relative to the housing,the propulsion element can be displaced by the discharge spring by anamount that corresponds to the thread pitch, for example.

The rotation element can be a threaded rod, for example, and thepropulsion element can have or be a threaded nut, wherein the thread ofthe threaded nut engages with the thread of the threaded rod.

In an alternative example, the rotation element can be a threaded nutand the propulsion element can have or be a threaded rod, wherein thethread of the threaded nut engages with the thread of the threaded rod.

The rotational element is preferably axially fixed in relation to thehousing, or can at least be supported axially fixedly in one direction,preferably the distal direction, on the housing or an element fixed tothe housing such as the abutment.

It is advantageous that the rotation element is connected rotationallyfixedly to the housing during the setting of a dose, i.e. in thenon-actuated state, by means of the clutch in particular, and is rotatedor rotatable during the actuation of the device to discharge the productdose. The driving and dosing device can have a dose setting or doseindicating device including a housing, a dose indicating elementincluding a dose scale, a pointing device, and a dosing element, and mayoptionally include a bearing element engaged and functionally operablewith the dose indicating element as described herein. The doseindicating element, particularly the dose indicating drum, can alsofundamentally be in threaded engagement with the housing or an elementarranged fixedly relative to the housing.

The dose indicating element, particularly the dose indicating drum, canbe rotatable relative to the rotation element during the setting of adose, i.e. in the non-actuated state of the driving and dosing device orthe actuating element. The dose indicating element is preferablyrotationally fixed relative to the rotation element during the actuationof the device in order to discharge the product dose and is axiallymovable, for example, or is rotationally fixedly connected to therotation element, in particular with the above-described clutch or someother clutch.

This has the advantageous effect that during discharging of the dose,i.e. during actuation of the actuating element, the discharge springscrews the dose indicating element back into its zero dose position,particularly via the rotation element and preferably via a clutchelement, which is preferably arranged rotationally fixedly but axiallydisplaceably in relation to the dose indicating element. In particular,the clutch element and the dose indicating element can be in arotationally fixed engagement that allows an axial movement between thedose indicating element and the clutch element. This engagement can beeffected by means of a longitudinal guide, for example. The clutchelement is preferably connected axially fixedly but rotatably to thebearing element.

For example, the driving and dosing device can have a first clutchstructure that is rotationally fixed in relation to the housing. Therotation element can have or form a second clutch structure that, whenin coupling engagement with the first clutch structure, causes therotation element to be rotationally fixed in relation to the housing.The first clutch structure can be formed by the housing for example, oran element arranged rotationally fixedly but axially displaceably inrelation to the housing, such as the bearing element or a clutchelement, particularly a sleeve-shaped one.

The clutch element can have a third clutch structure which, when engagedwith the first clutch structure or an additional, fourth clutchstructure of the rotation element, causes the dose indicating element tobe rotationally fixedly coupled to the rotation element. In thenon-actuated state of the device, the rotation element and the housingare rotationally fixed to one another; in particular, the first andsecond clutch structures are engaged, while the third and second oroptionally the third and fourth clutch structures are disengaged. In theactuated state, the third and second, and optionally the third andfourth clutch structures are engaged, while the first and second clutchstructures are disengaged from one another.

It is particularly advantageous if the dose indicating element isalready rotationally fixedly coupled to the rotation element and therotation element is still rotationally fixedly coupled to the housingwhile the actuating element is being pushed onto the housing foractuation. This ensures that the dose indicating element is firstcoupled securely to the rotation element when the rotation element hasbeen released for a rotation relative to the housing. In other words,there is an intermediate position between the actuated and non-actuatedposition of the actuating element, in which the rotation element is bothcoupled rotationally fixedly to the housing and also rotationallyfixedly to the dose indicating element. In particular, the first and thesecond and the third and the second clutch structures, and optionallythe third and the fourth, can be simultaneously engaged, namely when theactuating element occupies its intermediate position.

In generally preferred embodiments, the dose indicating element can havea stop, such as a zero dose stop, which is moved away from a matingstop, in particular a mating zero dose stop, whenever a dose isincreased and is moved toward the mating stop whenever a dose isreduced, or when the device is actuated for discharging the set productdose.

In particular, the dose indicating element can be at least rotationallydecoupled from the rotation element during setting of the product dose,i.e. dose increase and dose reduction and, during actuation of thedevice for discharging the product dose, can be coupled with therotation element in such a manner that a rotation of the rotationelement has the effect of moving the dose indicating element towards themating stop, i.e. the zero dose stop is moved towards the zero dosemating stop. If the zero dose stop and the zero dose mating stop arestopped or in contact, this prevents, particularly via the clutch, arotation of the rotation element and thus prevents further advancementof the propulsion element relative to the housing.

Between the dose setting element and the dose indicating element therecan be a dosing clutch, which couples the dose setting element to thedose indicating element rotationally fixedly if the driving and dosingdevice or the actuating element is non-actuated, and rotationallydecouples them if the driving and dosing device or the actuating elementis actuated. In other words, the dose indicating element and the dosingelement are coupled rotationally fixedly via the dosing clutch wheneverthe actuating element is non-actuated, and the dose indicating elementis rotatable relative to the dose setting element whenever the actuatingelement is actuated. The dosing clutch is opened by actuation of theactuating element.

In advantageous refinements, the driving and dosing device can comprisea mechanism for preventing the setting of a dose that exceeds thequantity of a medication in the product container. In particular, thismechanism can block rotation of the dosing element in a direction thatwould cause an increase of the dose, more particularly even if themaximum stop of the dose indicating element and the maximum dose matingstop are not yet engaged or if a dose is displayed in the pointingdevice that is smaller than the maximum adjustable product dose. Themechanism thus prevents setting a dose that exceeds the remaining amountof product contained in the product container, which reduces the dangerof misuse of the driving and dosing device. The mechanism can have alimiter, for example, which is positioned between two parts, of whichone rotates relative to the other during dose-setting and does notrotate during actuation, i.e. dose discharging. For example, the limitercan be arranged between the dose-setting element, which can be designedin particular as a dose-setting knob or dose-setting sleeve, and thehousing or an element fixed in relation to the housing. The limiter, thedose-setting element and the housing can be coupled to one another insuch a manner that a relative rotation, particularly duringdose-setting, between the dose-setting element and the housing causesthe limiter to move to a stop position in which the limiter preventssetting a dose that exceeds the amount of a product in the productcontainer. Examples of appropriately suitable limiters are disclosed inWO 2010/149209 or in WO 01/19434 A1, particularly in FIG. 3 thereof Forexample, the limiter can have an internal thread that is engaged with anexternal thread of the housing. In particular, the limiter can have alongitudinal guide on its outer side by which it is engaged with thedose-setting element such that the dose-setting element is rotationallyfixed relative to the limiter.

Alternatively, the housing can have the longitudinal guide for thelimiter, so that the limiter is rotationally fixed relative to thehousing and the limiter can have a thread, particularly an externalthread, that engages with a thread, particularly an internal thread, ofthe dose-setting element.

The stop position is defined by a stop for the limiter, wherein the stopcan be formed by the housing or the dose-setting element or a meansfixed relative to the housing at least axially or in the circumferentialdirection. If the limiter and the stop are in contact, a rotation of thedose-setting element in a direction that would cause an increase of thedose is no longer possible or is blocked.

In generally preferred refinements, particularly of the first and secondaspects, the driving and dosing device can have at least one signalgeneration mechanism, which is adapted to generate an acoustic and/ortactile signal, more particularly mechanically, during the dose-settingand/or the product discharging. Such a signal can be perceived as aclick signal. For example a (first) signal generation mechanism can beprovided, which generates the signal during the dose-setting and canoptionally be referred to as a dose-setting signal generation mechanism.In addition, a further (second) signal generation mechanism can beprovided, which generates the signal during the product discharging andcan optionally be referred to as a product discharge signal generationmechanism. Alternatively, a (common) signal generation mechanism can beprovided, which generates a signal during dose-setting and duringproduct discharging.

In general, the signal generation mechanism can be arranged between twoparts that move, more particularly rotate, relative to one anotherduring dose-setting and/or product discharging. One of the parts canhave a resiliently arranged catch element for example, which engageswith a toothing of the other one of the two parts, arranged across theperiphery thereof, for example. If one part is moved relative to theother, the catch element can slide over the toothing and generate thesignal. The toothing can be formed by an internal periphery or externalperiphery or an end face of the part.

In particular, the signal generation mechanism can be formed between theclutch element and the bearing element. The clutch element and thebearing element preferably rotate relative to one another duringdose-setting and product discharging, whereby a signal generationmechanism is formed that generates the signal during dose-setting andproduct discharging.

The signal generation mechanism can be formed in particular between thebearing element and the rotation element, wherein what has beenexplained for the bearing element applies here as well, at least in thepresent context, for a switching sleeve described herein. The bearingelement and the rotation element preferably rotate relative to oneanother during, more particularly only during, product discharging,whereby a signal generation mechanism is formed that generates a signalduring product discharging.

The signal generation mechanism can be formed in particular between theclutch element and the rotation element. The clutch element and therotation element preferably rotate relative to one another during, moreparticularly only during, dose-setting, whereby a signal generationmechanism is formed that generates a signal during dose-setting.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an exploded view of the individual parts of a firstembodiment of a driving and dosing device according to the invention,

FIGS. 2a-c show the driving and dosing device from FIG. 1 in an initialor delivery state, wherein FIG. 2b is a sectional view of FIG. 2a andFIG. 2c is a sectional view of FIG. 2a rotated by 90° along the lineB-B,

FIGS. 3a-c show the injection device in the views from FIG. 2a in astate in which the maximum adjustable dose has been set,

FIGS. 4a-c show the views from FIGS. 2a-c in which the dose set in FIGS.3a-c has been completely discharged and an actuating element is stillbeing actuated,

FIGS. 5a-c show the views from FIGS. 2a-c , wherein a driving element ofthe driving and dosing device has been blocked for a movement toincrease the dose, because the dose contained in the product containeris smaller than the maximum settable dose,

FIG. 6 shows an exploded view of the individual parts of a secondembodiment of a driving and dosing device according to the invention,

FIGS. 7a-c show the driving and dosing device from FIG. 6 in an initialor delivery state, wherein FIG. 7b is a sectional view of FIG. 7a andFIG. 7c is a sectional view of FIG. 7a rotated by 90° along the lineB-B,

FIGS. 8a-b show an exploded view of the individual parts of a thirdembodiment of a driving and dosing device according to the invention,wherein FIG. 8b is a sectional view of FIG. 8 a,

FIGS. 9a-c show the driving and dosing device from FIGS. 8a and 8b in aninitial or delivery state, wherein FIG. 9b is a sectional view of FIG.9a and FIG. 9c is a sectional view of FIG. 9a rotated by 90° along theline B-B,

FIGS. 10a-b show an exploded view of the individual parts of a fourthembodiment of a driving and dosing device according to the invention,wherein FIG. 10b is a sectional view of FIG. 10 a,

FIGS. 11a-c show the driving and dosing device from FIGS. 10a and 10b inan initial or delivery state, wherein FIG. 11b is a sectional view ofFIG. 11a and FIG. 11c is a sectional view of FIG. 11a rotated by 90°along the line B-B,

FIG. 12 shows an exploded view of the individual parts of a fifthembodiment of a driving and dosing device according to the invention,

FIGS. 13a-c show the driving and dosing device from FIG. 12 in aninitial or delivery state, wherein FIG. 13b is a sectional view of FIG.13a and FIG. 13c is a sectional view of FIG. 13a rotated by 90° alongthe line B-B,

FIG. 14 shows an exploded view of the individual parts of a sixthembodiment of a driving and dosing device according to the invention,

FIGS. 15a-c show the driving and dosing device from FIG. 14 in aninitial or delivery state, wherein FIG. 15b is a sectional view of FIG.15a and FIG. 15c is a sectional view of FIG. 15a rotated by 90° alongthe line B-B,

FIG. 16 shows a modified arrangement of discharge springs, and

FIG. 17 shows another modified arrangement of discharge springs.

DETAILED DESCRIPTION

In a first embodiment, as can be seen in FIGS. 1 and 2 a-2 c, forexample, the driving and dosing device comprises a sleeve-like housing 4that has an outer sleeve 4 b that can be gripped by the user with onehand. As can be recognized best from FIG. 2b , the housing 4 furthercomprises an inner sleeve 4 a, which forms an abutment 4 i and isarranged concentrically to the outer sleeve 4 b. Inner sleeve 4 a andouter sleeve 4 b are connected to one another via an annular web.Between the outer sleeve 4 b and the inner sleeve 4 a, an annular gap isformed, in which are arranged a dose indicating element 10, which isformed in particular as a dose indicating drum, i.e. in a sleeve-shape,a bearing element 9, and a clutch element 2, which is sleeve-shaped andcan also be referred to more particularly as a display clutch.

At the distal end of the housing 4, a sleeve-shaped product containerreceptacle 5 made from a preferably transparent material is arranged, inwhich a product container 14 in the form of a carpule is received. Theproduct container 14 is non-detachably connected to the housing 4 bymeans of the product receptacle 5, so that the driving and dosingdevice, together with the product container receptacle 5 and the productcontainer 14, forms a disposable injection device, which is, as a whole,disposable after complete emptying of the product container 14. At itsdistal end, the product container 14 has a septum 14 b, which can bepenetrated by a needle that can be positioned at the distal end of theproduct container 14 or the product container receptacle 5. A piston 14a is arranged in the product container 14, wherein the product to bedischarged is arranged between the septum 14 b and the piston 14 a.Adisplacement of the piston 14 a in the direction of the septum, or inthe distal direction, i.e. the discharging direction, thus effects adischarge of the product contained in the product container 14. Alsoshown in FIG. 1 is a protective cap 6, which can be placed over theproduct container receptacle 5 and is removed before injection of adose.

The housing 4, particularly the inner sleeve 4 a, is engaged with asleeve-shaped propulsion element 8, which can also be referred to as aplunger. The propulsion element 8 is rotationally fixed relative to thehousing 4 and is axially displaceable along the longitudinal axis L(FIG. 2a ). Between the inner sleeve 4 a and the propulsion element 8, aguide is formed by means of a longitudinal rib 8 a and at least onelongitudinal guide 4 c, which prevents a rotation of the propulsionelement 8 relative to the housing 4 and allows an axial movement of thepropulsion element 8 relative to the housing 4. The longitudinal rib 8 ais preferably formed by an outer sleeve of the propulsion element 8.

The propulsion element 8 has an inner sleeve 8 b, which in this examplehas an internal thread 8 c at its proximal end that engages with anexternal thread 1 a of a rotation element 1 embodied as a threaded rod.The propulsion element 8 is arranged such that its distal end 8 d canact on the piston 14 a, in particular can press against the piston 14 a.

The housing 4, in particular the proximal end of the inner sleeve 4 a,forms an abutment 4 i for a discharge spring 11, which is supported onthe abutment 4 i and in the area of the distal end of the propulsionelement 8. The spring 11 is supported at its distal end on an annularweb of the propulsion element 8, which connects the outer sleeve and theinner sleeve of the propulsion element 8. At its proximal end, thespring 11 is supported on the annular web formed by the housing 4 andprotruding inward, which forms the abutment 4 i.

The discharge spring 11 is formed as a helical or coil spring, whichacts as a compression spring and attempts to press the abutment 4 i andthe propulsion element 8 apart, i.e. to displace the propulsion element8 in the distal direction relative to the housing 4. At delivery of thedriving and dosing device, i.e. in the initial state thereof, thedischarge spring 11 is sufficiently preloaded that the energy stored init is sufficient to discharge the product contained in the productcontainer 14 substantially completely, in particular with a number ofindividual discharges, between each of which a new dose setting is made.The advantage of such a strongly preloaded spring is that the spring 11does not have to be cocked during dose-setting, whereby astrength-saving, i.e. simpler dose-setting is possible for the user ofthe device.

The threaded engagement between the propulsion element 8 and therotation element 1 is sufficiently strong that no self-locking of thethreaded engagement occurs, i.e. the rotation element 1 is turnable orrotatable relative to the propulsion element 8 about the longitudinalaxis L due to the axial force of the discharge spring 11.

The rotation element 1 is constructed as a threaded rod, which forms theexternal thread 1 a and has an enlarged diameter at its proximal end,more particularly in the shape of a broadened head. Teeth 1 b are formedparallel to the longitudinal axis L on the head and act as a secondclutch structure, as will be described below. An annular frictionsurface area with a diameter reduced in comparison to the head isarranged on the head and is in contact with the inward-protrudingannular web of the housing 4 that constitutes the abutment 4 i.Due tothe reduced diameter of the annular friction surface, the point ofattack of the resulting friction is shifted closer to the longitudinalaxis L, whereby the frictional moment between the rotation element 1 andthe housing 4 is reduced.

By rotating the rotation element 1 relative to the housing 4 and thepropulsion element 8, the spring 11 can displace the propulsion element8 by a discharge stroke in the distal direction that is proportional tothe angle of rotation of the rotation element 1. By selectively blockingand releasing the rotation element 1, which can be accomplished byactuating an actuation element 7 constructed as an actuating button, themovement of the propulsion element 8 relative to the housing 4, i.e. thedischarge stroke of the propulsion element 8, can be controlled in anadvantageous manner.

The driving and dosing device further comprises a bearing element 9,which can also be referred to as an indicating drum bearing element andis arranged rotationally fixedly relative to the housing 4 butdisplaceably along the longitudinal axis L. The bearing element 9 issleeve-shaped and preferably surrounds the inner sleeve 4 a of thehousing 4, wherein the outer sleeve 4 b in particular surrounds thebearing element 9. The bearing element 9 is engaged with the housing 4,more particularly the inner sleeve 4 a, which permits a longitudinalmovement of the bearing element 9 relative to the housing 4, butprevents a rotational movement. The engagement can be formed by alongitudinal guide 9 f between the bearing element 9 and the innersleeve 4 a.

The bearing element 9 has a thread 9 a, in particular an external threadwith which a thread 10 e, more particularity an internal thread, of thedose indicating element 10 engages. The dose indicating element 10 isscrewable relative to the bearing element 9 due to this threadedengagement.

The first embodiment further comprises a signal generation mechanism 2e, 9 b that generates an acoustic and/or tactile signal duringdose-setting and product discharging. The signal generation mechanism 2e, 9 b is arranged between the clutch element 2 and the bearing element9 and comprises in particular a catch element 2 e and a toothing 9 b.Thebearing element 9 has a toothing 9 b extending over the periphery, inparticular the outer periphery. The clutch element 2 has the resilientlyarranged catch element 2 e engaging with the toothing 9 b.

At the proximal end of the bearing element 9, the bearing element hasthe toothing 9 b extending over its circumference, the teeth of whichare used, for example, for setting discrete dose-proportional angularsteps and/or for producing a slight resistance during dose-settingand/or for generating an acoustic and/or tactile signal, e.g.

an audible and tangible click during dose-setting and productdischarging. Two catch elements 2 e, which are resiliently arranged oncatch arms and are formed by the clutch element 2, engage with thetoothing 9 b.The clutch element 2 is connected axially fixedly to thebearing element 9 and rotatably relative to the bearing element 9. Forthis purpose, the clutch element 2 engages by means of an annular groove2 c with a protrusion 9 d extending across the periphery of the bearingelement 9. A rotation of the sleeve-shaped clutch element 2 relative tothe bearing element 9 causes the catch elements 2 e to snap over thetoothing 9 b and produce the acoustic and/or tactile signal.

The dose indicating element 10 is rotationally fixedly but axiallydisplaceably connected to the clutch element 2, more particularlyengaged therewith. This engagement comprises a longitudinal guide 2 a,which causes the dose indicating element 10 to be rotationally fixedrelative to the clutch element 2, but axially displaceable. Because ofthe rotationally fixed connection between clutch element 2 and doseindicating element 10, a rotation of the clutch element 2 relative tothe bearing element 9 causes the dose indicating element 10 to likewisebe rotated and, due to the threaded engagement with the thread 9 a, tobe screwed along the bearing element 9, in particular, in addition tothe clicking sounds produced by the catch elements 2 e.

The dose indicating element 10 has a dose scale 10 b comprising aplurality of successively arranged scale values, that extends helically,corresponding to the pitch of the thread 10 e, over the outer peripheryof the dose indicating element. In the example shown, a maximum dose of80 IU can be set, the scale extending from 0 to 80 with dose valuesindicated in increments of two.

Likewise corresponding to the pitch of thread 10 e, a marking 10 a isarranged in a helical shape over the outer periphery of the doseindicating element 10. This marking 10 a is used, as will be describedbelow, to indicate whether the device is actuated or not actuated. Themarking 10 a is an optional device. It can extend along the entire dosescale 10 b or only parts or only a single scale value. In particular, itis only visible toward the end of product discharging or in the zeroposition when the driving and dosing device is actuated.

At its proximal end, for example, the dose indicating element 10 has astop surface 10 c pointing and acting in the circumferential direction,which is referred to as the zero dose stop. At the distal end, oppositethe proximal end, the dose indicating element 10 has a stop surface 10 dpointing and acting in the circumferential direction, which is referredto as the maximum dose stop.

The dose indicating element 10 can be screwed back and forth on thebearing element 9 between the zero dose position and the maximum doseposition. In the zero dose position, the zero dose stop 10 c, incooperation with a zero dose mating stop 4 f formed by the housing 4,prevents rotation of the dose indicating element 10 in a firstrotational direction, namely the rotational direction that would cause adose less than zero to be set. In this zero dose position, the doseindicating element 10 is rotatable in the opposite, i.e. second,rotational direction.

In the maximum dose position, shown in FIG. 3a for example, the maximumdose stop 10 d, in cooperation with the maximum dose mating stop 9 c,which is formed by the bearing element 9, prevents rotation of the doseindicating element 10 in the second rotational direction, which wouldcause an increase of the dose over the maximum settable value. Rotationin the first rotational direction is possible in the maximum doseposition. Although the maximum dose mating stop 9 c is formed by thebearing element 9, the maximum dose mating stop 9 c can optionally beformed, differing from the present example, by the housing 4. Differingfrom the example shown, the zero dose mating stop can be formed by thebearing element 9 for example.

The housing 4 has a pointing device 4 d in the form of a window, whichprovides a view of the scale 10 b of the dose indicating element 10. Adosing element 3 in the form of a dosing knob is mounted rotatably butaxially fixedly on the housing 4. For this purpose, the housing 4 has anannular groove 4 g with which an annular shoulder of the dosing element3 engages. The dosing element 3 has a grip structure 3 b across itsperiphery, which makes it easier for the user of the device to rotatethe dosing element 3 relative to the housing 4. In the non-actuatedstate of the device, a rotation of the dosing element 3 causes arotation or helical movement of the dose indicating element 10, wherebythe desired dose can be set and read out in the pointing device 4 d.

An actuating element 7 in the form of an actuating button is arranged onthe dosing element 3 and is movable relative to the dosing element 3, inparticular along the longitudinal axis L, for actuating the device forproduct discharging. The actuating element 7 forms the proximal end ofthe device and can be actuated, in particular displaced relative to thehousing 4 and/or the dosing element 3, in an easy manner by the thumb ofthe hand holding the housing 4. The clutch element 2 is rotatablerelative to the actuating element 7, particularly when the dosing clutch2 b, 3 c is released, and is axially fixed. The actuating element 7 ispreferably snapped together with the clutch element 2 axially fixedlybut rotatably.

The driving and dosing device additionally has a reset or clutch spring12, which is cocked during actuation, more particularly pressing, of theactuating element 7, and which returns the bearing element 9 and/or theactuating element 7 into its non-actuated position when the actuatingelement 7 is not actuated. Actuating the actuating element 7 causes, inaddition to the axial displacement thereof, the axial displacement ofthe bearing element 9 along the longitudinal axis L. The spring 12 ispreferably supported at its distal end on the dosing element 3, and atits proximal end, on the actuating element 7. The spring 12 ispreferably a helical spring or a coil spring, for example, acting as acompression spring.

The dosing element 3 is rotationally fixed relative to the actuatingelement 7. The actuating element 7 reaches through an inward-pointingshoulder of the dosing element 3. At the distal end of the preferablypot-shaped actuating element 7, a plurality of teeth are formed, whichtogether form a toothing 7 a that, due to the actuation of the actuatingelement 7, comes into engagement with a toothing 4 h formed on thehousing 4, particularly at the proximal end of the housing 4, wherebythe dosing element 3 is rotationally fixed in relation to the housing 4.The result of this is that setting a dose, i.e. a rotation of the dosingelement 3 relative to the housing 4, is not possible, but instead isonly possible if the actuating element 7 is non-actuated.

The dosing element 3 forms a clutch structure 3 c, more particularly atthe inward-protruding shoulder. The clutch structure 3 c interacts witha clutch structure 2 b on the outer periphery of the clutch element 2when the actuating element 7 is not actuated. In the non-actuated stateof the actuating element 7, the dosing element 3 and the clutch element2 are rotationally fixed relative to one another due to this clutchengagement. The clutch between the dosing element 3 and the clutchelement 2 can also be referred to as a dosing clutch 2 b, 3 c, which isengaged during dose-setting, i.e. when the actuating element 7 is notactuated, and is disengaged during dose discharging, i.e. when theactuating element 7 is actuated, the clutch transferring torque in theengaged state and not transferring torque in the disengaged state. Thedosing clutch 2 b, 3 c is disengaged or opened by a displacement of theclutch element 2 relative to the housing 4, more particularly byactuation of the actuating element 7.

The proximal end of the bearing element 9 has a first clutch structure 9e on the inner periphery, that is fanned by claws or teeth arrangedacross the periphery that engage with the teeth or claws of the rotationelement 1 forming the second clutch structure 1 b, more particularlywhen the actuating element 7 is not actuated. The rotation element 1 isrotationally fixed in relation to the housing 4 by means of this clutchengagement. On the inner periphery of the clutch element 2, there isadditionally a third clutch structure 2 d, which has a plurality ofteeth or claws distributed across the periphery. The third clutchstructure 2 d is arranged such that, when the actuating element 7 isactuated, the clutch structure comes into a rotationally fixedengagement with the rotation element 1, in particular with the secondclutch structure 1 b, or alternatively, a fourth clutch structureseparate from the second clutch structure 1 b, but not shown in thisexample.

While the actuating element 7 is being pushed for actuation along thelongitudinal axis L relative to the dosing element 3, the third clutchstructure 2 d first comes into engagement with the second clutchstructure 1 b.By further displacement of the actuating element 7relative to the dosing element 3, the first clutch structure 9 edisengages from the second clutch structure 1 b.Before, during orsimultaneously with the detachment of the engagement between the firstclutch structure 9 e and the second clutch structure 1 b, the clutchstructure 2 b disengages from the clutch structure 3 c and/or thetoothing 7 a engages with the teeth 4 h.

Particularly due to the fact that the first clutch structure 9 e isdetached from the second clutch structure 1 b, the discharge spring 11can relax, the rotation element 1 being rotated relative to the housing4; due to the engagement of the second clutch structure 1 b with thethird clutch structure 2 d, the clutch element 2 and thus also the doseindicating element 10 are rotated relative to the housing 4; thereby thedose indicating element 10 is screwed back into its zero dose positionand the propulsion element 8 is displaced, proportionally to thecircumferential distance between the zero dose stop 10 c and the zerodose mating stop 4 f, by a discharge stroke in the distal directionrelative to the housing 4. The rotation of the clutch element 2 relativeto the bearing element 9 causes the catch elements 2 e to snap over thetoothing 9 b, more particularly in dose-proportional angle steps, andproduce the acoustic and/or tactile signal.

The driving and dosing device has a dose limiter 13, in the form of aring, a ring segment or a nut, having a thread 13 b on its innerperiphery that engages with a thread 4 e arranged on the outer peripheryof the housing 4, so that the limiter 13 can be screwed relative to thehousing 4. At the outer periphery, the limiter 13 has an engagementelement 13 a, which engages in a longitudinal guide 3 a on the innerperiphery of the dosing element 3, so that the dose limiter 13 isrotationally fixed but axially displaceable relative to the dosingelement 3. A stop projection, from which the limiter 13 has a distanceproportional to the maximum product quantity that can be discharged fromthe product container 14, is formed on the dosing element 3 or thehousing 4. Since the dosing element 3 rotates relative to the housing 4during dose-setting and is not rotated during a dose discharge, thelimiter 13 can form a counting mechanism, which adds to the alreadydischarged individual doses and the currently set dose andcorrespondingly moves the housing 4 closer and closer to the stopprojection of the dosing element 3. A dose increase causes the limiter13 to be moved toward the stop projection. A dose reduction causes thelimiter 13 to be moved away from the stop projection. If the remainingdose indicated in the product container 14 is less than the maximum dosethat can be set with the driving and dosing device, the limiter 13 comesinto contact with the stop projection, so that a rotation of the dosingelement 3 relative to the housing 4 in a rotational direction that wouldresult in an increase of the dose is blocked.

The clutch formed from the first, second and third coupling structures 9e, 1 b, 2 d, as well as optionally the fourth coupling structure, canalso be referred to as a discharge clutch due to its interaction.

FIGS. 2a-2c show the driving and dosing device, which can also bereferred to as an injection device, in the initial or delivery state,more particularly the state before first usage. The product doseindicated in the pointing device 4 d is 0. Actuation of the actuatingelement 7 would result in no dose being discharged. The limiter 13 is adistance away from the stop projection that is proportional to thequantity of product contained or injectable in the product container 14,e.g. 300 IU.

To set the product dose, the dose setting element 3 is rotated relativeto the housing 4, whereby the coupling element 2 and thus also the doseindicating element 10 are rotated relative to the housing 4 due to theclutch engagement 2 b, 3 c.In the process, the dose indicating element10 screws along the bearing element 9 due to the thread engagement ofthe thread 10 e with the thread 9 a.

In particular, the distance between the zero dose stop 10 c and the zerodose mating stop 4 f is increased proportionally to the dose shown inthe pointing device 4 d.In addition, an audible and tactile signal isgenerated during rotation on the basis of the snapping of the catchelements 2 e over the toothing 9 b.

FIGS. 3a-3c show the driving and dosing device in a state in which amaximum settable dose has been set, namely 80 IU in this example, whichcan be read out in the pointing device 4 d.A further increase of thedose is not possible due to the interaction, more particularly thecontact, of the maximum dose stop 10 d with the maximum dose mating stop9 c.As can best be recognized from FIGS. 3b and 3c , the dose limiter 13has been advanced or shifted toward the stop projection corresponding to80 IU.

To discharge the dose shown for the sake of example in FIG. 3a , theactuating element 7 is actuated, more particularly pressed, i.e.displaced in the distal direction relative to the housing 4 and thedosing element 3, whereby the clutch element 2 and the bearing element 9as well as the dose indicating element 10 are displaced distallyrelative to the housing 4, more particularly against the force of thecoupling or reset spring 12. Because the dose indicating element 10 isdisplaced axially relative to the housing 4 and the pointing device 4 d,the marking 10 a shown in FIG. 1 appears in the pointing device 4 d(FIG. 4a ), whereby the user can read visually that the device has beenactuated. The displacement of the dose indicating element 10 relative tothe housing 4 and the pointing device 4 d moves the marking 10 a alongthe longitudinal axis L from a position in which it is concealed by thehousing 4 into a position in which it is shown in the pointing device 4d.

The actuation of the actuating element 7 additionally causes the thirdclutch structure 2 d to engage with the second clutch structure 1 b andthe first clutch structure 9 e to disengage from the second clutchstructure 1 b, so that the rotation element 1 is no longer rotationallyfixed in relation to the housing 4, but is rotatable and is rotationallyfixed in relation to the clutch element 2 and the dose indicatingelement 10. Actuating the actuating element 7 also causes the dosingclutch 2 b, 3 c to disengage or be opened and the front teeth 7 a toengage with the front toothing 4 h.In the actuated state of theactuating element 7, the rotation element 1 is rotationally fixedrelative to the dose indicating element 10, whereby the rotation element1 and the dose indicating element 10 can rotate jointly relative to thehousing 4. The force on the propulsion element 8 from the energy storedin the discharge spring 11 causes a rotation of the rotation element 1and the dose indicating element 10 relative to the housing 4 due to thethreaded engagement of the propulsion element 8 with the rotationelement 1, whereby the dose indicating element 10 is screwed back on thebearing element 9 in the direction of the zero dose position and thedose indicated in the pointing device 4 d is counted down. At the sametime, the propulsion element 8 is moved by the discharge spring 11 inthe distal direction relative to the housing 4 by the discharge stroke,which is proportional to the previously set dose. When the doseindicating element 10 has reached its zero position (FIGS. 4a-4c ), thepreviously set dose or single dose has been discharged. If the userreleases the actuating element 7, still shown pressed down in FIGS.4a-4c , the coupling or reset spring 12 resets the actuating element 7,the clutch element 2, the bearing element 9 and the dose indicatingelement 10 into the position shown for example in FIG. 2a , wherein themarking 10 a again disappears under the housing 4 or is concealed by thehousing 4. During resetting, the aforementioned elements are displacedin the proximal direction relative to the housing 4 or the dosingelement 3.

During resetting of the device by means of the spring 12, the firstclutch structure 9 e is engaged with the second clutch structure 1 b,and the third clutch structure 2 d is disengaged from the second clutchstructure 1 b.The rotation element 1 is now again rotationally fixed inrelation to the housing 4, the dosing element 3 again being rotatabletogether with the dose indicating element 10 relative to the housing 4and/or the pointing device 4 d and/or the rotation element 1 for anothersetting of a product dose or single dose. In addition, the fronttoothings 7 a and 4 h are released from engagement during resetting andthe dosing clutch 2 b, 3 c is reengaged, whereby the dosing element 3 isrotationally fixed relative to the clutch element 2 and the doseindicating element 10.

FIG. 5a shows the driving and dosing device in the position in which thelimiter 13 assumes its stop position, i.e. strikes against the stopprojection, whereby the limiter 13 blocks setting to a value thatexceeds the residual amount contained in the product container 14. Inthe example shown, the product container 14 still contains 76 IU, whilea maximum of 80 IU could be set with the driving and dosing device.Because the limiter 13 is already in contact with the stop projection at76 IU, the dosing element 3 is blocked from a rotation in the seconddirection, which would cause an increase of the dose. Decreasing thedose, however, is possible by turning the dosing element 3 in the firstrotational direction.

The dose shown in the pointing device 4 d is discharged by actuating theactuating element 7. Since the product container 14 is then completelyempty, the entire driving and dosing device, or injection device, isdisposed of. This is therefore a disposable injection device. Inprinciple however, the driving and dosing devices shown herein can alsobe used in connection with multiple-use injection devices, in which anempty product container 14 is exchanged for a new one.

A second embodiment of a driving and dosing device is shown in FIGS. 6-7c. The features that differ from those of the first embodiment will bedescribed below, and therefore the reader is referred to FIGS. 1-5 inother respects. Identical reference numbers designate parts that are atleast functionally equivalent.

The driving and dosing device differs from the embodiment of FIGS. 1-5particularly in that the discharge spring 11 is a torsion spring.

As can be best recognized from FIGS. 7b and 7c , the housing 4 comprisesan inner sleeve 4 a that is arranged concentrically with the outersleeve 4 b.Inner sleeve 4 a and outer sleeve 4 b are connected to oneanother via an annular web. The housing 4, particularly the annular web,forms an abutment 4 i for the distal end of the spring 11.

The propulsion element 8 does not include inner and outer sleeves inthis embodiment. The longitudinal rib 8 a is preferably foamed by thesleeve-shaped propulsion element 8. The propulsion element 8 has aninternal thread 8 c at its proximal end that engages with the externalthread 1 a of a rotation element 1 embodied as a threaded rod.

The housing 4, particularly the annular web connecting the outer andinner sleeves 4 a and 4 b, forms the, abutment 4 i for the dischargespring 11, which is supported at its proximal end on the abutment 4 i,and in the area of the head of the rotation element 1, rotationallyfixedly in each case.

The discharge spring 11 is formed as a helical or coil spring, whichacts as a torsion spring and attempts to twist the rotation element 1relative to the housing 4 and thereby indirectly displace the propulsionelement 8 in the distal direction relative to the housing 4. Atdelivery, i.e. in the initial state of the driving and dosing device,the discharge spring 11 is rotationally preloaded sufficiently that theenergy stored therein is sufficient to discharge the product containedin the product container 14 substantially completely, in particular witha number of individual discharges, between each of which a new dosesetting is made.

The threaded engagement between the propulsion element 8 and therotation element 1 can be, but need not be, sufficiently large that noself-locking of the threaded engagement occurs. The rotation element 1is turnable or rotatable relative to the propulsion element 8 about thelongitudinal axis L due to the torsional torque of the discharge spring11.

The spring 12 in this case is preferably supported at its distal end onthe rotation element 1, and at its proximal end, preferably on theactuating element 7. The spring 12 is preferably a helical spring or acoil spring, for example, acting as a compression spring.

The dosing element 3 is engaged rotationally fixedly with the actuatingelement 7. The actuating element 7 is displaceable relative to thedosing element in the discharge direction along the longitudinal axis L.The actuating element could 7 optionally also be designed according toone of the other examples, however, although this is not shown.

The catch element 2 e is arranged in the illustrated example in theproximal area of the clutch element 2, differing from the example ofFIGS. 1-5, where the catch element 2 e is arranged approximatelycentrally. The rotation of the clutch element 2 relative to the bearingelement 9, during product discharging and dose-setting for example,causes the catch element 2 e to snap over the toothing 9 b, moreparticularly in dose-proportional angle steps, and produce the acousticand/or tactile signal.

The torque on the rotation element 1 from the energy stored in thedischarge spring 11 causes a rotation of the rotation element 1 and thedose indicating element 10 relative to the housing 4, whereby the doseindicating element 10 is screwed back on the bearing element 9 in thedirection of the zero dose position and the dose indicated in thepointing device 4 d is counted down. At the same time, the propulsionelement 8 is moved by the discharge spring 11 in the distal directionrelative to the housing 4 by the discharge stroke, which is proportionalto the previously set dose. When the dose indicating element 10 hasreached its zero position, the previously set dose or single dose hasbeen discharged.

Although a limiter 13 is not shown in FIGS. 6-7 c, one can be providedin a manner described herein.

A third embodiment of a driving and dosing device is shown in FIGS.8a-9c . The features that differ from those of the first embodiment willbe described below, and therefore the reader is referred to FIGS. 1-5 inother respects. Identical reference numbers designate parts that are atleast functionally equivalent.

The driving and dosing device differs from the first embodimentparticularly in that it provides a signal generation mechanism 2 e, 1 cbetween clutch element 2 and rotation element 1 for signaling the dosesetting, and an additional signal generation element 1 b, 9 g betweenthe rotation element 1 and the bearing element 9 for signaling productdischarging. The signal generation mechanism 2 e, 1 c comprises inparticular the catch element 2 e of the clutch sleeve 2 and the internaltoothing 1 c of the rotation element 1. The signal generation mechanism9 g, 1 b comprises in particular the catch element 9 g of the switchingsleeve 15 and the toothing, i.e. the clutch structure, 1 b of therotation element 1.

Teeth, which are used as a second clutch structure 1 b, are arranged onthe outer periphery of the head of rotation element 1, parallel to thelongitudinal axis L. On the inner periphery of the head, which issurrounded by the outer periphery, a circumferential internal toothing 1c is arranged, with which at least one catch element 2 e of the clutchsleeve 2 engages, preferably at least when the actuation element 7 isnot actuated and particularly both when the actuating element 7 isactuated and not actuated.

A rotation of the sleeve-shaped clutch element 2 relative to therotation element 1, as during dose-setting for example, i.e. rotation ofthe dose-setting element 3 with a non-actuated actuating element 7,causes the at least one catch element 2 e to snap over the internaltoothing 1 c and generate the acoustic and/or tactile signal duringdose-setting.

Particularly at the proximal end of the bearing element 9, there is acatch element 9 g that is formed on an elastic catch arm and engageswith the second clutch structure 1 b, preferably at least with theactuating element 7 actuated, and in particular both with the actuatingelement 7 actuated and not actuated.

If actuating element 7 is actuated, i.e. if the engagement of the firstclutch structure 9 e is released by the second clutch structure 1 b, therotation element 1 can rotate relative to the housing 4 and the bearingelement 9, whereby the teeth of the second clutch structure 1 b snapover the at least one catch element 9 g of the bearing element 9 andgenerate the acoustic and/or tactile signal during product discharging.

A fourth embodiment of a driving and dosing device is shown in FIGS.10a-11c . The features that differ from those of the first embodimentwill be described below, and therefore the reader is referred to FIGS.1-5 in other respects. Identical reference numbers designate parts thatare at least functionally equivalent.

The driving and dosing device differs from the first embodimentparticularly in that the bearing element 9, with which the doseindicating element 10 engages by means of a thread, is absent and asignal generation mechanism 2 e, 1 c between the clutch element 2 andthe rotation element 1 for signaling the dose setting, and an additionalsignal generation element 9 g, 1 b between the rotation element 1 and aswitching sleeve 15 for signaling product discharging, are provided. Thesignal generation mechanism 2 e, 1 c comprises in particular the catchelement 2 e of the clutch element 2 and the internal toothing 1 c of therotation element 1. The signal generation mechanism 9 g, 1 b comprisesin particular the catch element 9 g of the bearing element 9 and theouter toothing, i.e. the second clutch structure 1 b, of the rotationelement 1.

The dose indicating element 10 is in threaded engagement with theexternal thread 9 a that is formed on the inner sleeve 4 a of thehousing 4. The effect of this is that the dose indicating element 10 canbe screwed back and forth on the housing 4, but is no longer axiallydisplaceable relative to the housing 4 or the pointing device 4 d apartfrom the screwing movement.

The task of the clutch and the generation of the signal during productdischarging are taken on by a switching sleeve 15 instead of the bearingelement 9. The switching sleeve 15 is rotationally fixed relative to thehousing 4, but is arranged to be displaceable along the longitudinalaxis L. The switching sleeve 15 preferably surrounds the inner sleeve 4a of the housing 4, while the clutch sleeve 2 in particular surroundsthe switching sleeve 15. The switching sleeve 15 is engaged with thehousing 4, more particularly the inner sleeve 4 a, which permits alongitudinal movement of the switching sleeve 15 relative to the housing4, but prevents a rotational movement. The engagement can be formed by alongitudinal guide 9 f between the switching sleeve 15 and the innersleeve 4 a.

In particular, the switching sleeve 15 has, at its proximal end, thecatch element 9 g, which is formed on an elastic catch arm and engageswith the second clutch structure 1 b, preferably at least when theactuating element 7 is actuated, and particularly both when theactuating element 7 is actuated and when it is not, and is used forgenerating an acoustic or tactile signal such as an audible and tactileclick during product discharging.

The clutch element 2 is connected axially fixedly to the switchingsleeve 15 and rotatably relative to the switching sleeve 15. For thispurpose, the clutch element 2 extends around the switching sleeve 15 atthe sides thereof pointing in the longitudinal direction by means of atleast one projection extending across the inner circumference of theclutch element 2. The switching sleeve 15 is thus—like the bearingelement 9—driven along by the displacement of the clutch element 2.

Teeth 1 b, which are used as a second clutch structure, are arranged onthe outer periphery of the head of rotation element 1, parallel to thelongitudinal axis L. On the inner periphery of the head, which issurrounded by the outer periphery, a circumferential internal toothing 1c is arranged, with which at least one catch element 2 e of the clutchsleeve 2 engages, preferably at least when the actuation element 7 isnot actuated and particularly both when the actuating element 7 isactuated and not actuated.

A rotation of the sleeve-shaped clutch element 2 relative to therotation element 1, as during dose-setting for example, i.e. rotation ofthe dose-setting element 3 with a non-actuated actuating element 7,causes the at least one catch element 2 e to snap over the internaltoothing 1 c and generate the acoustic and/or tactile signal duringdose-setting.

If actuating element 7 is actuated, i.e. if the engagement of the firstclutch structure 9 e with the second clutch structure 1 b is released,the rotation element 1 can rotate relative to the housing 4 and thebearing element 9, whereby the teeth of the second clutch structure 1 bsnap over the at least one catch element 9 g of the switching sleeve 15and generate the acoustic and/or tactile signal during productdischarging.

Due to the rotationally fixed connection between clutch element 2 anddose indicating element 10, a rotation of the clutch element 2 relativeto the switching sleeve 15 causes the dose indicating element 10 tolikewise be rotated and, due to the threaded engagement with the thread9 a, to be screwed along the inner sleeve 4 a, in particular, inaddition to the clicking sounds produced by the catch elements 2 e.

Actuating the actuating element 7 causes, in addition to the axialdisplacement thereof relative to the dosing element 3, the axialdisplacement of the switching sleeve 15 along the longitudinal axis L.The spring 12 is preferably supported at its distal end on the dosingelement 3, and at its proximal end, on the actuating element 7. Thespring 12 is preferably a helical spring or a coil spring, for example,acting as a compression spring.

A fifth embodiment of a driving and dosing device is shown in FIGS.12-13 c. The features that differ from those of the first embodimentwill be described below, and therefore the reader is referred to FIGS.1-5 in other respects. Identical reference numbers designate parts thatare at least functionally equivalent.

The embodiment from FIGS. 12-13 c differs from the first embodimentparticularly in that the rotation element 1 has a threaded nut, thepropulsion element 8 has or is a threaded rod 8 e, a signal generationmechanism 2 e, 1 b for signaling the dose-setting is arranged betweenthe clutch element 2 and the rotation element 1, and an additionalsignal generation mechanism 1 d, 9 h, for signaling the discharging ofproduct, is arranged between the rotation element 1 and the bearingelement 9. In addition, the limiter 13 is designed somewhat differentlyand the spring 12 is supported at its proximal end on the clutch element2, and at its distal end, on the rotation element 1. The signalgeneration mechanism 2 e, 1 b comprises in particular the catch element2 e of the clutch element 2 and the toothing, i.e. the second clutchstructure 1 b, of the rotation element 1. The signal generationmechanism 1 d, 9 h comprises in particular the catch element 1 d of therotation element 1 and the internal toothing 9 h of the bearing element9.

The housing 4, particularly the inner sleeve 4 a, is engagedrotationally fixedly with a propulsion element 8, which can also bereferred to as a plunger. The propulsion element 8 has a threaded rod 8e, which in this example has an external thread that engages in aninternal thread of the rotation element 1 embodied as a threaded nut.

The spring 11 is supported at its distal end on an annular web of thepropulsion element 8, which connects the threaded rod 8 e and the outersleeve of the propulsion element 8. At its proximal end, the spring 11is supported on the annular web formed by the housing 4 and protrudinginward, which forms the abutment 4 i.

The rotation element 1 is formed as a threaded nut, which forms theinternal thread, and has teeth serving as the second clutch structure 1b across its outer periphery parallel to the longitudinal axis L. Anannular friction surface area with a reduced inner diameter is arrangedat the distal end of the rotation element 1 and is in contact with theinward-protruding annular web of the housing 4 that constitutes theabutment 4 i.Due to the reduced diameter of the annular frictionsurface, the point of attack of the resulting friction is shifted closerto the longitudinal axis L, whereby the frictional moment between therotation element 1 and the housing 4 is reduced.

The clutch element 2 has a catch element 2 e, which engages with atoothing, more particularly the clutch structure 1 b, formed across theperiphery of the rotation element 1. A rotation of the sleeve-shapedclutch element 2 relative to the rotation element 1 causes the catchelements 2 e to snap over the second clutch structure 1 b and producethe acoustic and/or tactile signal.

At the distal end of the rotation element 1, or distally of the clutchstructure 1 b, the rotation element has the catch element 1 d, whichengages with the toothing 9 h formed across the inner periphery of thebearing element 9. The rotation of the rotation element 1 relative tothe bearing element 9 causes the catch element 1 d to snap over thetoothing 9 h and produce the acoustic and/or tactile signal duringdischarging of the product.

The bearing element 9 has an annular protrusion 9 d extended across theperiphery at the proximal end of the bearing element. The clutch element2 is connected axially fixedly to the bearing element 9 and rotatablyrelative to the bearing element 9. For this purpose, the clutch element2 engages with the protrusion 9 d by means of an annular groove 2 c.

The actuation element 7 is freely rotatable or rotationally fixedrelative to the dosing element 3, but is at least axially displaceable.A rotary bearing, which in the present example is formed by anapproximately point-like contact surface arranged on the axis ofrotation L of the clutch element 2, is formed between the actuationelement 7 and the clutch element 2. Alternatively, a sliding bearing inthe form of a sliding ring, made of Teflon for example, or a rollingbearing such as an axial ball bearing can serve as the rotary bearing.

The dose limiter 13, in the form of a ring in this example, has anexternal thread 13 c that engages with an internal thread 41 of thehousing 4, and on its internal periphery, has an engagement element 13a, which has a torsion-proof engagement with a longitudinal guide 3 a ofthe dosing element 3. In this way the dose limiter 13 is screwable byrotating the dosing element 3 relative to the housing 4. The internalthread 41 of the housing 4 is formed by an inner limiter sleeve 4 jconnected rotationally fixedly and axially fixedly to the outer sleeve 4b via connecting webs 4 k.The longitudinal guide 3 a is formed on theouter periphery of a dosing element inner sleeve, which is connectedaxially fixedly and rotationally fixedly to the outer sleeve of thedosing element 3, which can be gripped by the user. The inner sleeve ofthe dosing element 3 is arranged inside the inner limiter sleeve 4 j,the dose limiter 13 being arranged between the inner sleeve of thedosing element 3 and the inner limiter sleeve 4 j.

The sixth embodiment shown in FIGS. 14-15 c corresponds substantially tothe fifth embodiment, the signal generation mechanism 2 e, 9 b beingconstructed in principle as in the first embodiment. The signalgeneration mechanism 2 e, 9 b for signaling dose-setting and productdischarging is arranged between the clutch element 2 and the bearingelement 9 and comprises in particular the catch element 2 e and thetoothing 9 b.The bearing element 9 has the toothing 9 b extending overthe periphery. The clutch element 2 has the catch element 2 e engagingwith the toothing 9 b.

FIG. 16 presents a modification of the embodiments described herein thathas two discharge springs 11 a, 11 b acting as compression springs,which are connected in series. The first discharge spring 11 a issupported at its distal end on the propulsion element 8, and at itsproximal end, on an intermediate element 11 c.The second dischargespring 11 b is supported at its distal end on the intermediate element11 c, and at its proximal end, on the abutment 4 i.The second dischargespring 11 b is concentric with and arranged inside the first dischargespring 11 a.The sleeve-shaped intermediate element 11 c, which forms inparticular a support surface for the second injection spring 11 b at thedistal end of the intermediate element and a support surface for thefirst injection spring 11 a at the proximal end of the intermediateelement, is arranged between the first discharge spring 11 a and thesecond discharge spring 11 b.

FIG. 17 shows a modification of the embodiments described herein thatcomprises two discharge springs 11 a and 11 b acting as compressionsprings, which are connected in parallel. The first discharge spring 11a and the second discharge spring 11 b are supported at their distal endon the propulsion element 8, and at their proximal ends on the abutment4 i.The second discharge spring 11 b is concentric with and arrangedinside the first discharge spring 11 a.The sleeve-shaped intermediateelement 11 c, which prevents the two discharge springs 11 a, 11 b frombecoming entangled with one another, is arranged between the firstdischarge spring 11 a and the second discharge spring 11 b.

What is claimed is:
 1. A driving and dosing device configured torepeatedly set a dose and administer the dose from an injection devicefor administering a liquid product, the driving and dosing devicecomprising: a) a housing; b) a dosing element configured to be grippedby a user and to be rotated relative to the housing for setting the doseto be administered; c) an actuating element configured to be actuated bythe user, wherein the actuating element is displaceable relative to thedosing element to discharge the set dose; d) an abutment; e) apropulsion element comprising a distal end configured for acting on apiston of a product container fixed or fixable to the device, whereinthe propulsion element is movable relative to the abutment in adischarge direction in order to discharge the set dose; f) a springconfigured to act between the propulsion element and the abutment,wherein the spring is preloaded upon delivery of the device withsufficient energy to discharge the product contained in the productcontainer substantially completely; g) a rotation element configured torotate relative to the housing, wherein selectively releasing rotationof the rotation element relative to the housing permits the spring tomove the propulsion element in the discharge direction; and h) a clutchconfigured for releasably engaging the rotation element, wherein theclutch releases the rotation element such that the rotation elementrotates relative to the housing when the actuating element is actuated,and blocks the rotation of the rotation element relative to the housingwhen the actuating element is released.
 2. The driving and dosing deviceof claim 1, wherein the spring comprises at least one of: a compressionspring supported on the propulsion element and the abutment or a torsionspring supported on the rotation element and the abutment.
 3. Thedriving and dosing device of claim 1, wherein the propulsion element isconfigured to be guided on the housing or on an element fixed inrelation to the housing.
 4. The driving and dosing device of claim 1,wherein the spring is configured to drive the propulsion element in thedischarge direction and the propulsion element is configured to drivethe rotation element.
 5. The driving and dosing device of claim 1,wherein the rotation element comprises a threaded rod in an engagementwith a threaded nut of the propulsion element or the rotation elementcomprises a threaded nut in an engagement with a threaded rod of thepropulsion element.
 6. The driving and dosing device of claim 1, furthercomprising a dose indicating element comprising a stop, wherein the stopis configured to move away from a mating stop during dose setting when adose is being increased, and wherein the stop is configured to movetoward the mating stop during dose setting when the dose is beingreduced or when the actuating element is actuated for discharging theset dose.
 7. The driving and dosing device of claim 6, wherein the doseindicating element is at least rotationally decoupled from the rotationelement during the setting of the dose when the dose is being increasedor reduced, and when the actuating element is actuated to discharge theset dose, the dose indicating element is coupled to the rotation elementsuch that rotation of the rotation element causes the dose indicatingelement to be moved toward the mating stop.
 8. The driving and dosingdevice of claim 1, wherein the dosing element is configured to berotationally decoupled from the spring at least during dose-setting,such that the spring is not cocked or released during dose-setting. 9.The driving and dosing device of claim 1, further comprising at leastone signal generation mechanism configured to generate an acousticsignal, a tactile signal or both during at least one of dose-setting ordose discharge.
 10. The driving and dosing device of claim 1, furthercomprising a dose indicating element comprising a dose scale arrangedover an exterior of the dose indicating element and a pointing device,wherein by rotating the dosing element relative to the pointing deviceto set the dose, the dose indicating element can be rotated or screwedrelative to the pointing device about an axis of rotation such that avalue of the dose scale corresponding to a set dose can be read by meansof the pointing device.
 11. The driving and dosing device of claim 10,wherein the actuating element comprises an intermediate position betweenan actuated position and a non-actuated position, wherein in theintermediate position, the rotation element is coupled rotationallyfixedly to both the housing and the dose indicating element.
 12. Thedriving and dosing device of claim 10, further comprising a dosingclutch configured to couple the dosing element to the dose indicatingelement when the actuating element is not actuated and is configured torotationally decouple the dose-setting element and the dose indicatingelement when the actuating element is actuated, wherein the dosingclutch is provided between the dose-setting element and the doseindicating element.
 13. The driving and dosing device of claim 12,further comprising an additional clutch configured to cause the doseindicating element to be rotatable relative to the rotation element whenthe actuating element is not actuated and to cause the dose indicatingelement to be rotationally fixed relative to the rotation element whenthe actuating element is actuated.
 14. The driving and dosing device ofclaim 10, further comprising a second clutch configured for releasablyengaging the dosing element and the dose indicating element, whereinwhen the actuating element is actuated, the second clutch rotationallydecouples the dosing element and the dose indicating element, andwherein when the actuating element is not actuated, the dosing clutch isconfigured to rotationally couple the dosing element with the doseindicating element.
 15. The driving and dosing device of claim 1,further comprising: i) a pointing device; j) a dose indicating elementcomprising a dose scale arranged over an exterior of the dose indicatingelement; and k) a bearing element in an engagement with the doseindicating element, wherein the dosing element is rotatable relative tothe pointing device and by rotating the dosing element, the doseindicating element can be rotated or screwed relative to the pointingdevice about an axis of rotation such that a value of the dose scalecorresponding to a set dose can be read by means of the pointing device,wherein the engagement of the bearing element with the dose indicatingelement causes a rotational movement or a screwing movement of the doseindicating element relative to the pointing device, and wherein thebearing element and the dose indicating element are displaceablerelative to the housing and along the axis of rotation in a distaldirection.
 16. The driving and dosing device of claim 15, wherein thebearing element is arranged rotationally fixedly relative to the housingbut displaceably along a longitudinal axis L in the distal direction.17. The driving and dosing device of claim 15, wherein the bearingelement, the dose indicating element and a body of the pointing deviceare movable relative to the housing and along the axis of rotation. 18.The driving and dosing device of claim 1, further comprising a doseindicating element comprising a dose scale arranged over an exterior ofthe dose indicating element and a pointing device, wherein rotation ofthe dosing element to set the dose slaves the dose indicating element inrotation relative to the pointing device about an axis of rotation suchthat a value of the dose scale corresponding to a set dose can be readby means of the pointing device.
 19. A driving and dosing deviceconfigured to repeatedly set a dose and administer the dose from aninjection device for administering a liquid product, the driving anddosing device comprising: a) a housing; b) a dosing element configuredto be gripped by a user and to be rotated relative to the housing forsetting the dose to be administered; c) an actuating element configuredto be actuated by the user, wherein the actuating element isdisplaceable relative to the dosing element to discharge the set dose;d) an abutment, wherein the abutment is defined by at least one of thehousing or an element fixed in relation to the housing; e) a propulsionelement comprising a distal end configured for acting on a piston of aproduct container fixed or fixable to the device, wherein the propulsionelement is movable relative to the abutment in a discharge direction inorder to discharge the set dose; f) a spring configured to act betweenthe propulsion element and the abutment, wherein the spring is preloadedin a delivery state of the device with sufficient energy that saidspring can discharge a maximum dischargeable product quantity from theproduct container in a plurality of individual discharges; g) a rotationelement configured to rotate relative to the housing, whereinselectively releasing rotation of the rotation element relative to thehousing permits the spring to move the propulsion element in thedischarge direction; and h) a clutch configured for releasably engagingthe rotation element, wherein the clutch releases the rotation elementsuch that the rotation element rotates relative to the housing when theactuating element is actuated, and blocks the rotation of the rotationelement relative to the housing when the actuating element is released.20. A driving and dosing device configured to repeatedly set a dose andadminister the dose from an injection device for administering a liquidproduct, the driving and dosing device comprising: a) a housing; b) adosing element configured to be gripped by a user and to be rotatedrelative to the housing for setting the dose to be administered; c) anactuating element configured to be actuated by the user, wherein theactuating element is displaceable relative to the dosing element todischarge the set dose; d) an abutment; e) a propulsion elementcomprising a distal end configured for acting on a piston of a productcontainer fixed or fixable to the device, wherein the propulsion elementis movable relative to the abutment in a discharge direction in order todischarge the set dose; f) a spring configured to act between thepropulsion element and the abutment, wherein the spring is preloaded ina delivery state of the device with sufficient energy to discharge theproduct contained in the product container substantially completely,wherein the dosing element is configured to be rotationally decoupledfrom the spring at least during dose-setting, such that the spring isnot cocked or released during dose-setting; g) a rotation elementconfigured to rotate relative to the housing, wherein selectivelyreleasing rotation of the rotation element relative to the housingpermits the spring to move the propulsion element in the dischargedirection; and h) a clutch configured for releasably engaging therotation element, wherein the clutch releases the rotation element suchthat the rotation element rotates relative to the housing when theactuating element is actuated, and blocks the rotation of the rotationelement relative to the housing when the actuating element is released.